Drug product
Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly labeled as 150.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
D-0908-2017
Product summary
- Event
- Event 77191
- Status
- Terminated
- Classification
- Class II
- Quantity
- 144 bags
- Official record key
drug-enforcement:D-0908-2017
Official wording
Reason: Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Code information: Lot Numbers: 170020074D, 4/3/2017; 170050071D, 4/6/2017; 170270036D, 4/30/2017
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Not Elsewhere Classified: Incorrect